Boston Scientific recalls WATCHMAN FXD Curve Access System (UPN M635TS80010) due to higher risk of air embolism during procedures without positive pressure ventilation. Affected patients may have increased risk of negative left atrium pressure and air ingress.
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Boston Scientific is recalling its WATCHMAN FXD Curve Access System (UPN M635TS80010) because it can cause air embolisms during procedures without proper ventilation. This risk is higher for patients with low left atrial pressure, hypovolemia, or partial airway collapse.
The device can cause negative pressure in the left atrium during procedures without positive pressure ventilation, leading to air entering the bloodstream. This risk is higher for patients with pre-existing low left atrial pressure, hypovolemia, or partial airway collapse.
Patients undergoing procedures with this device, especially those with low left atrial pressure, hypovolemia, or partial upper airway collapse. Medical professionals performing the procedures are most at risk.
The device has a Material Number (UPN) M635TS80010. It was sold with GTIN 00191506013820 and is part of the WATCHMAN FLX LAAC Device family.
Look for the Material Number (UPN) M635TS80010 on the device packaging or label.
The device can cause air embolism events during procedures without positive pressure ventilation, increasing the risk of negative left atrium pressure and air ingress, especially in patients with low left atrial pressure, hypovolemia, or partial airway collapse.
Patients with pre-existing low left atrial pressure, hypovolemia, or partial upper airway collapse during procedures using this device.
The recall record does not specify a remedy.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2429-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2429-2025 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
